Commission Regulation (EC) No 108/2007 of 5 February 2007 amending Regulation (EC) No 1356/2004 as regards the conditions for authorisation of the feed additive Elancoban, belonging to the group of coccidiostats and other medicinal substances (Text with EEA relevance )
Date: 2007-02-05
Institutions: European Commission
Subjects: animal nutrition, food additive, food safety, market approval, poultry, veterinary drug

L 31/4

EN

Official Journal of the European Union

6.2.2007

COMMISSION REGULATION (EC) No 108/2007

of 5 February 2007

amending Regulation (EC) No 1356/2004 as regards the conditions for authorisation of the feed
additive Elancoban, belonging to the group of coccidiostats and other medicinal substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

the
Having regard to Regulation (EC) No 1831/2003 of
the Council of 22 September
European Parliament and of
2003 on additives for use in animal nutrition (1) and in
particular Article 13(3) thereof,

Whereas:

(1)

(EC) No

The
additive monensin sodium (Elancoban G100,
Elancoban 100, Elancogran 100, Elancoban G200,
Elancoban 200) was authorised under certain conditions
in accordance with Council Directive 70/524/EEC (2).
1356/2004 (3)
Regulation
Commission
authorised that additive for 10 years
for use for
chickens for fattening, chickens reared for laying and
turkeys,
authorisation to the person
responsible for putting that additive into circulation.
That additive was notified as an existing product on
the basis of Article 10 of Regulation (EC) No
1831/2003. Since all
the information required under
that provision was submitted, that additive was entered
into the Community Register of Feed Additives.

linking

the

(2)

Regulation (EC) No 1831/2003 provides for the possi-
bility of modifying the authorisation of an additive
further to a request from the authorisation holder and
an opinion of the European Food Safety Authority (the
the
Authority). The holder of

the authorisation of

additive monensin sodium (Elancoban G100, Elancoban
100, Elancogran 100, Elancoban G200, Elancoban 200)
has submitted an application which proposes changing
the terms of the authorisation by introducing maximum
residue limits (MRLs) as evaluated by the Authority.

In its opinion adopted on 21 November 2006,
the
Authority proposed to establish provisional MRLs for
the active substance concerned (4). It may be necessary
to review the MRLs set out in the Annex in the light of
the results of a future evaluation of that active substance
by the European Medicines Agency.

Regulation (EC) No 1356/2004 should therefore be
amended accordingly.

The measures provided for in this Regulation are in
accordance with
Standing
Committee on the Food Chain and Animal Health,

opinion

the

the

of

(3)

(4)

(5)

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Regulation (EC) No 1356/2004 is replaced by the
text in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 5 February 2007.

For the Commission

Markos KYPRIANOU
Member of the Commission

(1) OJ L 268, 18.10.2003, p. 29. Regulation as

amended by
Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005,
p. 8).

(2) OJ L 270, 14.12.1970, p. 1. Directive repealed by Regulation (EC)

No 1831/2003.

(3) OJ L 251, 27.7.2004, p. 6.

(4) Opinion of

the Scientific Panel on Additives and Products or
Substances used in Animal Feed on the Maximum Residues Limits
for monensin sodium for chicken and turkeys for fattening, adopted
on 21 November 2006, The EFSA Journal (2006) 413, p. 1-13. See
also Opinion of the Scientific Panel on Additives and Products or
Substances used in Animal Feed on the request of the Commission
on the re-evaluation of coccidiostat Elancoban in accordance with
article 9G of Council Directive 70/524/EEC, adopted on 4 March
2004, The EFSA Journal (2004) 42, p. 1-61.

6.2.2007

EN

Official Journal of the European Union

L 31/5

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